Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT04328142
• Lead Sponsor: University of Extremadura

Brief Summary

This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.

Detailed Description

Objective:

This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme for the improvement of the quality of life of subjects with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

University of Extremadura, Spain

Subjects:

Women with Fibromyalgia

Interventions:

141 Participants were randomized to a Qigong exercise program group (n=47), a physiotherapy treatment group (n=47) and control group (n=47) for 6 weeks.

Main Measures:

Measures were taken at baseline (week 0), pre intervention (week 1) and post intervention (week 6). The primary outcome measure were quality of life (Spanish Fibromyalgia Impact Questionnaire (SFIQ), pain (VAS), perceive exertion (Borg scale), spirometry measures (Spirobank-G MIR spirometry) and balance (Wii-Fit, Nintendo ©). The secondary outcome measures were flexibility (Wells and Dillon test and Sit and Reach test), Range of movement (goniometer), muscle strength (Lowett scale).

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2013-09-30
• Study Completion: 2013-09-30
• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

• women between 30 and 65 years old,
• diagnosed with Fibromyalgia by a specialized physician,

Exclusion Criteria

• The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.
Changes from the values registered by the Spirobank-G (MIR)® spirometer	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222
Change from the centre of gravity registered with Wii-fit Nintendo®	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance
Change from the monopodal stance test registered with Wii-fit Nintendo®	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.
Change from Visual Analogue Scale (VAS) at post intervention (week 6)	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.
Change from Borg Scale of perceived exertion at post intervention (week 6)	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.

Secondary Outcome Measures

Name	Time	Method
Change from range of movement measured with goniometer	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Shoulder and hip range of movement
Change from muscle strength measured with Lovett scale	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Shoulder and hip range of movement.Lovett scale is a modification of Daniels and Worthingham. The scale is measured from 0 to 5 where 0 means no muscle activation strength and 5 means normal strength against resistance
Change from flexibility measured with the Wells y Dillon scale	Baseline (week 0), pre intervention (week 1) and post intervention (week 6).	Flexibility is measured with this scale with the patient sitting and reaching the feet. It is measured in centimeter and a more positive value means a better record.